Recall Z-1448-04 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Inc.
Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
| Date | Sep 14, 2004 (initiated Aug 3, 2004) |
| Status | Terminated |
| Reason | The polyethylene tibial bushing was omitted from the taper of the tibial plates. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians. |
| Distribution | Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013385 | NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE Zimmer, Inc., Jan 9, 2002 |